Filter for Fine Needle Biopsy

ABSTRACT

A biopsy needle comprises a first lumen open to a tissue penetrating distal tip of the needle for receiving a tissue sample therein and a second lumen in combination with a filter separating the first and second lumens from one another, the filter being configured to permit fluids to pass therethrough while preventing the sampled tissue from passing therethrough

PRIORITY CLAIM

The present application is a Continuation of pending U.S. patentapplication Ser. No. 15/141,604 filed on Apr. 28, 2016; which is aContinuation of U.S. patent application Ser. No. 14/549,178 filed onNov. 20, 2014, now U.S. Pat. No. 9,351,711; which is a Continuation ofU.S. patent application Ser. No. 14/273,043 filed on May 8, 2014, nowU.S. Pat. No. 8,920,337, which is a Continuation of U.S. patentapplication Ser. No. 14/104,713 filed on Dec. 12, 2013, now U.S. Pat.No. 8,753,288; which is a Continuation of U.S. patent application Ser.No. 13/973,656 filed on Aug. 22, 2013, now U.S. Pat. No. 8,632,476;which is a Continuation of U.S. patent application Ser. No. 12/871,003filed on Aug. 30, 2010, now U.S. Pat. No. 8,591,434; which claims thepriority to U.S. Provisional Patent Application Ser. No. 61/241,677,entitled “Filter for Fine Needle Biopsy,” filed on Sep. 11, 2009. Theentire disclosure of these patents/applications are expresslyincorporated herein by reference.

BACKGROUND

Needle biopsies are often performed to diagnose and/or stage variouspathologies. In these procedures, various size needles (i.e., 19G, 22G,25G) are often employed. However, these procedures are often inefficientin that the sampled biopsy material is obscured by unwanted matter(e.g., blood). Specifically, due to the increased trauma associated withpuncturing tissue, an undesirable amount of blood may inadvertently bedrawn into a needle diluting the sample and making it more difficult toanalyze the sample.

SUMMARY OF THE INVENTION

The present invention is directed to a biopsy needle comprising a firstlumen open to a tissue penetrating distal tip of the needle forreceiving a tissue sample therein and a second lumen in combination witha filter separating the first and second lumens from one another, thefilter being configured to permit fluids to pass therethrough whilepreventing the sampled tissue from passing therethrough.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a longitudinal cross-sectional view of a needle accordingto a first exemplary embodiment of the present invention; and

FIG. 2 shows a longitudinal cross-sectional view of a needle accordingto a second exemplary embodiment of the present invention ;

FIG. 3 shows a longitudinal cross-sectional view of a needle accordingto a third exemplary embodiment of the present invention;

FIG. 4 shows a longitudinal cross-sectional view of a needle accordingto a fourth exemplary embodiment of the present invention; and

FIG. 5 shows a perspective view of a needle coupled to a syringe.

DETAILED DESCRIPTION

The present invention, which may be further understood with reference tothe following description and the appended drawings, relates to devicesfor conducting biopsy procedures and in particular, to biopsy needles.Exemplary embodiments of the present invention provide a needle with afiltration mechanism to separate sampled target tissue from unwantedmaterials to obtain larger, undiluted samples.

An exemplary needle according to the present invention comprises anendoscopic ultrasound-guided fine-needle aspiration (“EUS-FNA”) devicefor performing biopsy procedures on a living body. The needle of thepresent invention comprises two concentrically formed chambers separatedfrom one another by a filter. The filter comprises a wall formed withmultiple openings therein sized to allow cells of unwanted tissue toflow therethrough from one chamber to another while preventing thetarget tissue from passing between the chambers. Accordingly, targettissue brought into the needle according to any known method along withany unwanted material (e.g., blood) first enters a first chamberextending longitudinally through the needle. The blood drawn into theneedle flows through the openings into the second chamber and isseparated from the target tissue which can not pass through the filter.

As shown in FIG. 1, a device 100 according to an exemplary embodiment ofthe invention includes a needle 101 housed within a protective sheath102 formed of any suitable biocompatible material as would be understoodby those skilled in the art. The sheath 102 may, for example, besubstantially rigid and includes a lumen sized and shaped to slidablyreceive the needle 101 therein. The needle 101 may be a 22 G needle asis commonly employed to obtain histological samples held within an outertube 112 received within the sheath 102. The outer tube 112 ispreferably 19 G and is separated from the needle 101 by an annular space105 extending therearound. In a preferred embodiment, the needle gaugeis within the range of 19G-25G, as known to those of skill in the artand, in one embodiment, may be selected such that a volume of theannular space 105 is greater than a volume of the needle 101 situatedtherein. In a preferred embodiment, the size of the annular space 105 isselected so that the acquired tissue sample is not compressedtherewithin. It is noted, however, that this is not a requirement of thepresent invention and the annular space 105 may be formed with anydimensions without deviating from the scope of the present invention.The needle 101, which may be formed as a hypotube, includes alongitudinal body 106 extending from a proximal end (not shown) to adistal end comprising an open, puncturing tip 108 extending distally ofa sealed distal end 114 of the outer tube 112. The proximal end (notshown) of the needle 101 further comprises a seal (e.g., a Touhy-Borstseal) configured to prevent the flow of air, fluids, etc. thereoutof.The seal permits a vacuum applied to the proximal end (not shown) to betransferred to the distal end of the needle 101. The seal (not shown) isalso configured to permit advancement and retraction of a stylet 111received through the needle 101, as described in greater detailhereinafter. In an alternate embodiment, the needle 101 does not extendthrough the full length of the sheath 102 but rather, only along apredetermined distal portion thereof. In one preferred embodiment, theneedle 101 may extend approximately 0.305 meters from the distal end ofthe device 100. A proximal end of the needle 101 is then located aselected distance from the distal end and is operably connected to thestylet 111, which extends from the proximal end of the needle to aproximal end of the device 100 accessible to a user. In this embodiment,the stylet 111 is provided with a latching mechanism (not shown) thatprevents the distal end of the stylet 111 from disengaging a proximalend of the needle 101. The latching mechanism (not shown) may be formedas a flattened portion on the stylet 111 configured to engage aprotrusion formed on a proximal end of the needle 101, whereinengagement of the flattened portion with the protrusion preventsmovement of the stylet 111 therepast. The protrusion may be formedaround a periphery of the proximal end of the needle 101 so the rotationof the needle 101 does not dislodge the stylet 111 therefrom.

A lumen 104 extends through the needle 101 and a plurality of openings110 formed along at least a portion of the longitudinal body 106 extendthrough a wall of the needle 101 to the lumen 104 providing forcommunication between the lumens 104 and 105. The openings 110 in thisembodiment are formed along a substantially helical pattern, distributedevenly around a circumference of the longitudinal body 106. It is notedhowever, that the openings 110 may be formed in any pattern orarrangement on the needle 101 without deviating from the scope of thepresent invention. For example, in an alternate embodiment (not shown),the openings 110 may be situated along only a portion of a circumferenceof the needle 101. The diameter of each of the openings 110 is selectedto allow non-targeted materials to pass through while being too small topass target tissue. For example, where the non-targeted material isblood, each opening 110 may have a diameter of approximately 8-10 μmallowing red blood cells to flow therethrough while preventing harvestedtarget tissue from passing out. In an alternate embodiment, each of theopenings 110 may comprise a diameter in the range of 1 μm-250 μm toconform to the requirements of a target procedure. As the diameters ofcell clusters of most tissue biopsies are greater than that of red bloodcells, the openings 110 effectively function as a red blood cell filter,permitting only liquid and red blood cells to flow therepast into thelumen 105 while maintaining the target tissue in the lumen 104. Thelumen 104 includes the stylet 111 therein which may be advanced into theopen distal end 108 of the needle 101 to prevent foreign matter fromentering the needle 101 during insertion. After the needle 101 has beenadvanced to the target site, the stylet 111 is withdrawn proximally intothe needle 101 and the target tissue mass is penetrated to permit atarget tissue sample to enter the lumen 104. Then, when the needle 101has been withdrawn from the body, the stylet 111 may be advanceddistally through the lumen 104 to eject the target tissue sampletherefrom. It is further noted that the openings 110 are not restrictedto circular apertures and may comprise any size and shape including, butnot limited to, slits, slots, non-circular openings and any combinationor pattern incorporating multiple sizes or shapes. Furthermore, the sizeof the openings may be chosen to accommodate the size of the cells to befiltered therethrough, as those skilled in the art will understand.

The outer tube 112 is seated within the protective sheath 102 and thedistal end 114 thereof is sealed and tapered inward toward the needle101. An end of the tapered distal end 114 is proximal with respect tothe puncturing tip 108 of the needle 101 so that, when the distal tip108 is pushed into target tissue, the larger diameter outer tube 112 mayremain outside the target tissue mass reducing trauma thereto.Furthermore, the outer tube 112 is sized such that a frictional forcebetween the outer tube 112 and the sheath 102 is minimized and, suchthat a small annular space lies therebetween in an operativeconfiguration. It is noted that, although the present embodiment isdescribed with a rounded tapered distal end 114, the distal end of theouter tube 112 may be formed of any shape including, but not limited toa square. Furthermore, the outer tube 112 may be attached to the needle101 by any means known in the art such as adhesive bonding.

The needle 101 of the present invention may be used in a mannersubstantially similar to current procedures for the use of variousEUS-FNA devices. Specifically, the device 100 is inserted into a livingbody via any known guiding apparatus as would be understood by thoseskilled in the art (e.g., under ultrasound guidance) until a distalportion thereof is adjacent to a target tissue mass to be sampled. Asdescribed above, during insertion the stylet 111 is advanced to adistal-most resting position with a distal end thereof seated in theopening at the distal tip 108 to prevent non-targeted tissue fromentering the needle 101. When the target tissue portion has beenreached, the stylet 111 is withdrawn proximally into the lumen 104 tocreate a space within which the tissue sample will be received. Theneedle 101 is then advanced distally into the target tissue drivingtarget tissue into the distal end of the lumen 104. Specifically, theneedle 101 is driven distally relative to the sheath 102 (e.g., by anyknown mechanism) to extend distally beyond the distal end 114 andpenetrate the target tissue mass. As noted earlier, the portion of theneedle 101 extending distally beyond the distal end 114 of outer tube112 may be of any length depending on the requirements of a procedure tobe performed. The sheath 102 may then be sized accordingly, so that,when retracted, the needle 101 is housed completely therein. Once thetarget tissue has been penetrated by the needle 101 and a sample of thetarget tissue has been forced into the distal end of the lumen 104,unwanted material is drawn out of the tissue sample by applying negativepressure to the lumen 105 (e.g., via a syringe 300 coupled to a proximalend thereof as illustrated in FIG. 5). This pressure draws the blood orother unwanted material through the holes 110 into the lumen 105 whilethe targeted sample of tissue is prevented from passing therethrough andremains in the lumen 104. After the sampling process has been completed,the device 100 is withdrawn proximally from the guiding device andremoved from the body. The stylet 111 is once again advanced distally toeject the target biopsy material from the lumen 104 for analysis.

A device 200 according to an alternate embodiment of the inventionincludes a needle 201 including a substantially constant diameter outerbody 202. The outer body 202 extends to an open, tissue penetratingdistal tip 208 with a lumen 205 extending therethrough. It is noted thatalthough the embodiment of FIG. 2 is shown with particular dimensions,the dimensions of the lumen 205 and the body 202 may be modified in anyof a plurality of ways depending on the requirements of the proceduresto be performed. The device 200 further includes a stylet 216 sized andshaped for slidable insertion through the lumen 205 so that a distal endof the stylet 216 may seal the distal opening to the lumen 205. Whenretracted proximally into the needle 201, the distal end of the stylet216 is withdrawn into the lumen 205 so that sample tissue may enter thelumen 205.

As described above, during insertion of the needle 201 to a targettissue sampling site, the stylet 216 is advanced to a distalmostlocation in the lumen 205 to prevent unwanted tissue from entering theneedle 201. An outer diameter of the stylet 216 is selected to beslightly less than an inner diameter of the lumen 205 so that it may beslidably received therein. The distal end of the stylet 216 is sealed sothat, when in the distal-most position, the sealed distal end thereofprevents material from entering the lumen 205 via the opening in thedistal tip 208. A plurality of openings 210 extend through the stylet216, opening a lumen 214 extending therethrough to the lumen 205. Asdescribed in regard to the device 100 of FIG. 1, the openings 210 may bedistributed substantially evenly around a circumference thereof (e.g.,along a helical path) or in any desired pattern or distribution.Alternatively, the openings 210 may be placed in any desired positionsalong any desired path. As with the embodiment of FIG. 1, the openings210 may comprise a diameter of approximately 8-10 μm, to allow red bloodcells to pass therethrough while preventing the passage of targettissue.

When a target tissue area has been reached in the body, the stylet 216is withdrawn proximally into the cavity 206 and the needle 201 isadvanced distally (e.g., out of a guiding device) so that the puncturingtip 208 enters the target tissue. As would be understood by thoseskilled in the art, negative pressure may be transmitted through thestylet lumen 214 to the target tissue to aid in drawing target tissueinto the lumen 205. It is noted that the stylet 216 is only partiallyretracted into the lumen 205, allowing enough clearance for a biopsysample to enter therein without obstruction.

As with the device 100 of FIG. 1, the device 200 is advanced to adesired location adjacent to a target tissue mass to be sampled usingany known means with the stylet 216 in the distal-most position toprevent the introduction of non-targeted tissue into the lumen 205. Whenthe needle 204 has reached the desired position, the stylet 216 iswithdrawn proximally into the lumen 205 to free a space therewithin toreceive target tissue. The needle 204 is then inserted into the targettissue so that target tissue is forced into the lumen 205 via theopening in the distal tip 208. The user then reduces the pressure withinthe lumen 214 (e.g., via a vacuum source attached at the proximal end ofthe stylet lumen 214). This reduced pressure is communicated to thelumen 205 via the openings 210 and draws the contents of the lumen 205toward the openings 210. As the openings 210 are sized to permit thepassage of fluids such as blood therethrough while preventing passage oftargeted tissue, the fluids are drawn into the lumen 214 while thetarget tissue remains within the lumen 205. If desired, the fluids maybe withdrawn from the lumen 214 via a syringe (such as the syringe 300of FIG. 5) or other mechanism as would be understood by those skilled inthe art to prevent it from returning to the cavity 206 where it woulddilute the target tissue sample. The device 200 is withdrawn from thebody and the stylet 216 may be advanced distally to force the tissuesample out of the needle 204 via the opening in the distal tip 208.

In an alternate embodiment of the device of FIG. 2, a proximal portionof the stylet 216 may be tapered. In another alternate embodiment, theopenings 210 may be replaced with a filter material placed at a distaltip of the stylet 216.

It will be apparent to those skilled in the art that variousmodifications and variations may be made to the structure andmethodology of the present invention without departing from the spiritor scope of the invention. For example, the exemplary needle of thepresent invention may be formed with any of various tip grinds.Furthermore, the filtering of fluid through the exemplary embodiment ofthe present invention need not be limited to openings in the hypotubeand may include a filtering medium (e.g., a non-woven fiber plug)situated on the needle to assist in filtering. The filtering medium canbe situated similar to the openings of FIGS. 1 and 2 or, in an alternateembodiment, may be placed over a distal opening of the needle, as thoseskilled in the art will understand. For example, as shown in FIG. 3, thefiltering medium may be a membrane 116 extending along a portion of thelongitudinal body 106 housed within the large diameter outer tube 112.In another example, as shown in FIG. 4, the filtering medium may be aplug 118 disposed within the lumen 104 of the longitudinal body 106.Still further, the annular space 105 or cavity 206 that receives theunwanted tissue and other matter, can assume any shape known in the artand is not limited to symmetrical embodiments. Thus, the presentinvention covers all modifications and variations so as they come withinthe scope of the appended claims and their equivalents.

1.-19. (canceled)
 20. A method for performing a needle biopsy,comprising: advancing a biopsy needle with a tissue penetrating distaltip to penetrate a target portion of tissue to capture a sample of thetarget tissue within an opening at a distal end of a longitudinal bodyof the biopsy needle, the biopsy needle including a first lumenextending therethrough, the longitudinal body slidably received in thefirst lumen of the outer tube, the longitudinal body including a secondlumen extending therethrough, the longitudinal body having an outerdiameter selected to form a space between an inner surface of the outertube and an outer surface of the longitudinal body, the biopsy needfurther including a stylet slidably received in the first lumen, thestylet including a distal end operably connected to a proximal end ofthe longitudinal body; and reducing a pressure within the second lumenof the longitudinal body to pass fluids through a plurality of openingsextending through the longitudinal body, the openings permitting fluidcommunication between the second lumen and the space, a size of theopenings being selected to permit the openings to operate as a filterpermitting the fluids to pass from the second lumen to the space whilepreventing the captured tissue from passing therethrough.
 21. The methodaccording to claim 20, further comprising: coupling a latching mechanismto prevent a proximal end of the stylet from disengaging a proximal endof the outer tube.
 22. The method according to claim 21, wherein thelatching mechanism includes a flattened portion on the stylet engaging aprotrusion formed on the proximal end of the outer tube.
 23. The methodaccording to claim 23, wherein the flattened portion engaging theprotrusion prevents the proximal end of the stylet from movingproximally past the protrusion.
 24. The method according to claim 20,wherein a cross-sectional shape of the outer tube and the longitudinalbody is symmetrical.
 25. The method according to claim 24, wherein thecross-sectional shape is circular.
 26. The method according to claim 25,wherein the protrusion is formed around a periphery of the proximal endof the outer tube.
 27. The method according to claim 20, furthercomprising: forming a seal about the longitudinal body with a distal endof the first lumen.
 28. The method according to claim 27, wherein theproximal end of the outer tube includes a proximal port coupeable to asource of negative pressure to aspirate fluids therefrom, the sealfacilitating a withdrawal of the fluids from the second lumen into thespace via an application of suction to the first lumen.
 29. The methodaccording to claim 20, wherein the stylet is accessible to a user formanual movement of the longitudinal body.
 30. The method according toclaim 20, wherein the at least one opening is between approximately 1 μmand 250 μm in diameter.